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Ortho Clinical Diagnostics Inc. (QuidelOrtho)

FDA 510(k) & PMA Approved Devices — 3 products

Total Devices3
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K254264 Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIAQVF2026-09-04 View
510(k) K254262 Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIAPSZ2026-09-04 View
510(k) K254295 Sofia Lyme FIA; Sofia 2 Campylobacter FIALSR2026-07-10 View
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